TUI 3D in Diagnosis of Placenta Accreta: Comparison With Gray-scale and Color Doppler Techniques

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02712099

Enrollment

Registered

2016-03-18

Start date

2015-08-31

Completion date

2016-03-31

Last updated

2017-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Placenta Accreta

Brief summary

The purpose of this study is to evaluate the potential of the 3 D TUI view in diagnosis of morbidly adherent placenta in comparison to 2D grayscale, color Doppler and intraoperative findings.

Detailed description

* This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital. * All patients will undergo the following : 1. History taking 2. Clinical examination. 3. For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

1. History of previous cesarean section or hysterotomy. 2. Placenta previa with its lower edge covering the scar of previous cesarean section 3. From 28 wks to Full term.

Exclusion criteria

1. Multiple pregnancies. 2. Medical disorder as diabetes mellitus, hypertension. 3. Obese patients. BMI \> 30 4. Intrauterine growth retardation.

Design outcomes

Primary

Measure	Time frame	Description
Loss of the Retro Placental Sonolucent Zone by 2D Grayscale Ultrasonography	28 -36 weeks of gestation	2D grayscale ultrasonography criteria of placenta accreta by Loss of the retro placental sonolucent zone in placenta previa with its lower edge covering the scar of previous cesarean section
Abnormal Placental Lacunae by 2D Grayscale Ultrasonography	28 -36 weeks of gestation	2D grayscale ultrasonography criteria of placenta accreta by Abnormal placental lacunae in placenta previa with its lower edge covering the scar of previous cesarean section

Secondary

Measure	Time frame	Description
Crowded Vessels Over Peripheral Sub-placental Zone by Power Doppler Ultrasonography	28 -36 weeks of gestation	Power Doppler ultrasonography criteria of Crowded vessels over peripheral sub-placental zone of in placenta previa with its lower edge covering the scar of previous cesarean section
Abnormal Placental Lacunae by Power Doppler Ultrasonography	28 -36 weeks of gestation	Power Doppler ultrasonography criteria by Abnormal placental lacunae in placenta previa with its lower edge covering the scar of previous cesarean section
Crowded Vessels Over Peripheral Sub-placental Zone by 3D Tomographic Ultrasound Imaging (TUI)	28 -36 weeks of gestation	the examiner can simultaneously display, on the monitor or on a hard copy, up to 24 preselected parallel cuts from a volume. The slices can be generated either along the initial or any other reconstructed plane of the region of interest (ROI) in intervals of 0.5 - to 5 mm segments. Slice thickness will be adjusted as necessary for each individual case. The most informative image among the multiple images will be displayed with the use of CrossXBeam, a postprocessing tool that allows one to enhance tissue and border differentiation, leading to sharper depiction of the tissue margins
Abnormal Placental Lacunae by 3D Tomographic Ultrasound Imaging (TUI)	28 -36 weeks of gestation	3D tomographic ultrasound imaging (TUI) of placenta previa with its lower edge covering the scar of previous cesarean section the examiner can simultaneously display, on the monitor or on a hard copy, up to 24 preselected parallel cuts from a volume. The slices can be generated either along the initial or any other reconstructed plane of the region of interest (ROI) in intervals of 0.5 - to 5 mm segments. Slice thickness will be adjusted as necessary for each individual case. The most informative image among the multiple images will be displayed with the use of CrossXBeam, a postprocessing tool that allows one to enhance tissue and border differentiation, leading to sharper depiction of the tissue margins

Participant flow

Recruitment details

study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital from August 2015 to march 2016. Fifty pregnant women In whom the transabdominal scan revealed evidence of anterior placenta previa were recruited from the the Fetal Care Unit who fulfilled the inclusion criteria.

Participants by arm

Arm	Count
Women With Placenta Previa Who Had Easily Placenta Delivery This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital. • All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation. Intraoperative: * Delivery of the fetus through the placenta. * 15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers. 30 Women with placenta previa who had easily placenta delivery	30
Women With Placenta Previa Who Had Difficult Placenta Delivery This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital. • All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation. Intraoperative: * Delivery of the fetus through the placenta. * 15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers. * When not separated easily manual removal was done, with uterotonics, together with uterine massage. 20 Women with placenta previa who had difficult placenta delivery	20
Total	50

Baseline characteristics

Characteristic	Total	Women With Placenta Previa Who Had Easily Placenta Delivery	Women With Placenta Previa Who Had Difficult Placenta Delivery
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	50 Participants	30 Participants	20 Participants
Race and Ethnicity Not Collected	0 Participants	—	—
Region of Enrollment Egypt	50 participants	30 participants	20 participants
Sex: Female, Male Female	50 Participants	30 Participants	20 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 30	0 / 20
serious Total, serious adverse events	0 / 30	0 / 20

Outcome results

Primary

Abnormal Placental Lacunae by 2D Grayscale Ultrasonography

2D grayscale ultrasonography criteria of placenta accreta by Abnormal placental lacunae in placenta previa with its lower edge covering the scar of previous cesarean section